hERG: Technology and Market Analysis

Chapter 1: Executive Summary

Scope of This Report

Why is hERG becoming so crucial in Drug Discovery and Development?

What are the strategic opportunities in the hERG marketplace?

Summary of hERG as a Toxicity Marker for Drug Discovery and Development and the Associated Market Opportunity

Chapter 2: hERG - The Channel, Its Physiological Role, and Drug Toxicity

Scope of This Chapter

Long QT Syndrome (LQTS) and Torsades de Pointes

Biology of hERG and its Role in QT Prolongation

hERG: A Promiscuous Target for Drug Interactions

Molecular Modeling of hERG: Predictive In silico Modeling for hERG Channel

Blockers and Features-Motifs of hERG Rendering it Promiscuous

Affecting the Biological Function of hERG Other than by Blocking its Channel with Drugs

In Conclusion- hERG and Drug-induced LQTS

Chapter 3: Experimental Approaches for Screening hERG

Scope of This Chapter

What is the experimental problem that needs to be addressed?

Requirements for hERG Toxicity Screening

In vitro and in vivo Approaches to hERG Channel Screening

Chapter 4: Market Analysis of the hERG Space

Scope of This Chapter

End-User Survey: Data and Analysis

Quantitative Market Opportunity and Market Model

Chapter 5: Company Pro.les

Scope of This Chapter

Aurora Biomed

AVIVA Biosciences Corporation

Cellular Dynamics International

CEREP

ChanTest

CreaCell

Cyprotex

Cytomyx Ltd.

Flyion GmbH

MDS Pharma Services

Molecular Devices Corporation

Neurion Pharmaceuticals, Inc

Quintiles Transnational Corp

Sophion Bioscience A/S

Appendix I: Drugs Inducing Torsades de Pointes (TdP)

Appendix II: Industry Presentation of Biological Properties, Market Landscape, and Regulatory Guidelines of hERG

TABLE OF EXHIBITS

Exhibit 1.1 High Pro.le Drug Withdrawals from the Marketplace

Exhibit 2.1 Normal Cardia Cycle (EKG)

Exhibit 2.2 Long QT Syndrome and Torsades de Pointes

Exhibit 2.3 Various Currents Involved in the Cardiac Normal Rhythm

Exhibit 2.4 Schematic Structure of the hERG Channel

Exhibit 2.5 Schematic Structure of the hERG Channel Illustrating the Large Ligan-binding Pocket Lined with Aromatic Residues

Exhibit 2.6 Drug Block of hERG Channels Expressed in HEK293 Cells

Exhibit 2.7 Pharma Blockbusters Taken Off the Market Due to hERG Inference

Exhibit 2.8 hERG Interacts with a Large Number of Drugs in Different Therapeutic Classes

Exhibit 2.9 The Total IhERG (hERG current) Depends on a Number of Factors

Exhibit 3.1 IKr current and QT Prolongation

Exhibit 3.2 Requirements for Technology to be Adopted into the hERG Screening Marketplace

Exhibit 3.3 A comparison of Technical Aspects of in vitro Approaches to Screen hERG K+ Channels

Exhibit 4.1 Key Challenges in the hERG Marketplace

Exhibit 4.2 Technology and Market Trends in the hERG Toxicity Screening Space

Exhibit 4.3 Bottlenecks in the Toxicity Screening Space

Exhibit 4.4 What are the Drivers for Deployment of hERG in Toxicity Screening Space?

Exhibit 4.5 In terms of Market Opportunity, What % of Toxicity Screening Addresses hERG?

Exhibit 4.6 Total Size of an hERG Screening Campaign within the Respondents Institution? - In terms of Assay Points per Week, Month, and Year

Exhibit 4.7 Cost Per Assay Point that the Pharmaceutical Industry Currently Pays to Screen for hERG and what Fraction of hERG Screening is Outsourced

Exhibit 4.8 All the Technologies Used for hERG Screening Mentioned by our Respondent Pool and Vendors in this Space

Exhibit 4.9 What is the Future of hERG?

Exhibit 4.10 Quantitative Market Model Presenting the Opportunity and Revenues in the hERG Marketplace

Exhibit 4.11 Market Size for hERG Screening of Lead Compounds

Exhibit 4.12 In-house Versus Outsourced hERG-based Toxicity Screening in Pharma and Biotech

Exhibit 4.13 Market Opportunity for hERG-based Toxicity Screening Segregated via In-house Screening versus Outsourced Screening

Exhibit 4.14 hERG-based Toxicity Screening: Product Sales and Fee-for-Service Offered by Vendors